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Pharsight Uses FDA Disease Model to Support Oncology Drug Development
Date:11/20/2007

y Decisions: Data/models of Diseases, Drugs, Placebo, Baseline, and Dropouts." Additional information can be found at http://www.diahome.org or requested from FDA at pharmacometrics@fda.hhs.gov.

"As outlined in FDA's Critical Path Initiative, model-based drug development offers an important approach to improving drug development knowledge management and decision-making," said Shawn O'Connor, president, chief executive officer, and chairman of Pharsight. "We are pleased that FDA has shared their NSCLC survival model with the public to describe prior knowledge in this area. With our unmatched collective modeling expertise, Pharsight scientists are uniquely positioned to help our clients build, adapt, and extend drug-disease models in their own development programs. Over the past three years, we have supported more than 30 oncology programs and modeling initiatives for industry clients, from pre-clinical to Phase III and covering critical issues in trial design, dose selection, and development strategy. We look forward to collaborating with our client to share feedback with FDA, and to contributing to ongoing industry discussions on opportunities for sharing drug-disease models to support quantitative decision-making in clinical development."

About Pharsight Corporation

Pharsight Corporation develops and markets integrated products and services that enable pharmaceutical and biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products. Pharsight's goal is to help customers reduce the time, cost and risk of drug development, as well as optimize the post-approval marketing and use of pharmaceutical products.

Pharsight's approach enhances the fundamental element of drug development success: strong decision-making. By adopting the Pharsight approach, customers acquire a new decision-making process with the potential to systematically imp
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SOURCE Pharsight Corporation
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